Tool to use image for programming neuromodulation

ABSTRACT

A system may be used with a medical imaging system and a programming system. The medical imaging system may be configured to display a medical image and the programming system may be configured to implement a program used in programming a neuromodulation device. The system may comprise a mobile device having at least one processor, a camera and a user interface including a display. The mobile device may be configured to acquire a displayed medical image from the medical imaging system, determine based on the acquired medical image location data indicative of the position of at least one of the electrodes relative to at least one of the anatomy or at least another one of the electrodes, and provide the location data for use by the program implemented by the programming system.

CLAIM OF PRIORITY

This application is a continuation of U.S. patent application Ser. No.16/568,063, filed on Sep. 11, 2019, which claims the benefit of priorityunder 35 U.S.C. § 119(e) of U.S. Provisional Patent Application Ser. No.62/737,222, filed on Sep. 27, 2018, each of which is herein incorporatedby reference in its entirety.

TECHNICAL FIELD

The present disclosure relates generally to medical devices, and moreparticularly, to systems, devices, and methods used in programmingneuromodulation.

BACKGROUND

Neural modulation has been proposed as a therapy for a number ofconditions. Often, neural modulation and neural stimulation may be usedinterchangeably to describe excitatory stimulation that causes actionpotentials as well as inhibitory and other effects. Examples ofneuromodulation include Spinal Cord Stimulation (SCS), Deep BrainStimulation (DBS), Peripheral Nerve Stimulation (PNS), and FunctionalElectrical Stimulation (FES). SCS, by way of example and not limitation,has been used to treat chronic pain syndromes. Some neural targets maybe complex structures with different types of nerve fibers within acomplex three dimensional environment. It is desirable to improve theprecision of neural targeting and field shapes to for deliveringneuromodulation to targeted regions within these complex structures.

SUMMARY

This Summary includes examples that provide an overview of some of theteachings of the present application and not intended to be an exclusiveor exhaustive treatment of the present subject matter. Further detailsabout the present subject matter are found in the detailed descriptionand appended claims. Other aspects of the disclosure will be apparent topersons skilled in the art upon reading and understanding the followingdetailed description and viewing the drawings that form a part thereof,each of which are not to be taken in a limiting sense. The scope of thepresent disclosure is defined by the appended claims and their legalequivalents.

An example (e.g. Example 1) of subject matter (such as a system, adevice, apparatus or machine) may be used with a medical imaging systemand a programming system. The medical imaging system may be configuredto display a medical image and the programming system may be configuredto implement a program used in programming a neuromodulation device. Thesystem may comprise a mobile device having at least one processor, acamera and a user interface including a display. The mobile device maybe configured to acquire a displayed medical image from the medicalimaging system where the displayed medical image includes arepresentation of anatomy and a representation of at least one lead andwhere the at least one lead includes electrodes, based on the acquiredmedical image determine location data indicative of the position of atleast one of the electrodes relative to at least one of the anatomy orat least another one of the electrodes, and provide the location datafor use by the program implemented by the programming system, whereinthe programming system is configured to use the location data inprogramming the neuromodulation device.

In Example 2, the subject matter of Example 1 may optionally beconfigured such that the mobile device is configured to receive, usingthe user interface, user input annotating the acquired image to providean annotated image.

In Example 3, the subject matter of any one or any combination ofExamples 1-2 may optionally be configured such that the mobile device isconfigured to use the at least one processor to provide a reconstructedimage for use by the programming system by reconstructing therepresentation of the at least one lead including electrodes on ananatomical template image.

In Example 4, the subject matter of any one or any combination ofExamples 1-3 may optionally be configured such that the medical imagingsystem includes a fluoroscopy imaging system and the displayed image isa fluoroscopic image that includes a representation of at least one leadimplanted proximate to a spine.

In Example 5, the subject matter of any one or any combination ofExamples 1-4 may optionally be configured such that the mobile deviceincludes a phone.

In Example 6, the subject matter of any one or any combination ofExamples 1-5 may optionally be configured such that the acquired imageincludes an image from a picture taken by the camera of the mobiledevice.

In Example 7, the subject matter of any one or any combination ofExamples 1-6 may optionally be configured such that the acquired imageis a transitory image on the mobile device that is available forannotating the image and determining the location data but is notretrievably stored on the mobile device.

In Example 8, the subject matter of any one or any combination ofExamples 1-7 may optionally be configured such that the mobile device isconfigured to directly communicate with the programming system toprovide the location data for use by the program implemented by theprogramming system.

In Example 9, the subject matter of any one or any combination ofExamples 1-8 may optionally be configured such that the mobile device isconfigured to provide the location data to the neuromodulation device,and the programming system is configured to receive the location datafrom the neuromodulation device.

In Example 10, the subject matter of any one or any combination ofExamples 1-9 may optionally be configured such that the system isconfigured to move the location data from the mobile device to a cloudlocation and from the cloud location to the programming system.

In Example 11, the subject matter of any one or any combination ofExamples 1-10 may optionally be configured such that the system isconfigured to display the annotated image with adjustable markers, andthe adjustable markers are configured to be adjusted by the user toaccommodate individual spinal anatomy.

In Example 12, the subject matter of any one or any combination ofExamples 1-11 may optionally be configured such that the annotated imageincludes at least one marker to identify at least one of vertebrallevels or laterality within the annotated image.

In Example 13, the subject matter of any one or any combination ofExamples 1-12 may optionally be configured such that the mobile deviceis configured to use the annotated image to determine location dataindicative of the positions of the electrodes and the anatomy.

In Example 14, the subject matter of any one or any combination ofExamples 1-13 may optionally be configured such that the system includesa cloud device configured to use the annotated image to determinelocation data indicative of the positions of the electrodes and theanatomy.

In Example 15, the subject matter of any one or any combination ofExamples 1-14 may optionally be configured such that the location datais usable by the programming system to determine energy contributionsfor the electrodes.

An example (e.g. Example 15) of subject matter (e.g. a method, a meansfor performing acts, or a machine-readable medium including instructionsthat, when performed by the machine, cause the machine to perform acts)may be performed using a medical imaging system and a programmingsystem. The medical imaging system may be configured to display amedical image and the programming system may be configured to implementa program used in programming a neuromodulation device. The subjectmatter may include acquiring a displayed medical image from the medicalimaging system, wherein the displayed medical image includes arepresentation of anatomy and a representation of at least one lead,wherein the at least one lead includes electrodes, receiving user inputannotating the acquired image to provide an annotated image, based onthe acquired medical image determine location data indicative of theposition of at least one of the electrodes relative to at least one ofthe anatomy or at least another one of the electrodes, providing areconstructed image for use by the programming system by reconstructingthe representation of the at least one lead including electrodes on ananatomical template image, and providing the location data for use bythe programming system to program the neuromodulation device.

In Example 17, the subject matter of Example 16 may optionally beconfigured such that the programming system is configured to use thelocation data to determine energy contributions for the electrodes.

In Example 18, the subject matter of any one or any combination ofExamples 16-17 may optionally be configured such that the medicalimaging system includes a fluoroscopy imaging system and the displayedimage is a displayed fluoroscopic image, and the displayed imageincludes a representation of at least one lead implanted proximate to aspine.

In Example 19, the subject matter of any one or any combination ofExamples 16-18 may optionally be configured such that acquiring thedisplayed image includes receiving a clipped image to capture a portionof the displayed fluoroscopoic image.

In Example 20, the subject matter of any one or any combination ofExamples 16-19 may optionally be configured such that acquiring thedisplayed image includes receiving an image from a picture taken of thedisplayed fluoroscopic image, wherein the picture is taken using acamera from a mobile device.

In Example 21, the subject matter of any one or any combination ofExamples 16-20 may optionally be configured such that the acquired imageis a transitory image on the mobile device that is available forannotating the image and determining the location data but is notretrievably stored on the mobile device.

In Example 22, the subject matter of any one or any combination ofExamples 16-21 may optionally be configured such that receiving userinput annotating the acquired image includes using the mobile device toreceive user input to annotate the acquired image.

In Example 23, the subject matter of any one or any combination ofExamples 16-22 may optionally be configured such that using theannotated image to determine location data includes using the mobiledevice to determine the location data from the annotated image or usingthe programming system to determine the location data from the annotatedimage.

In Example 24, the subject matter of any one or any combination ofExamples 16-23 may optionally be configured such that using theannotated image to provide a reconstructed image includes using themobile device to provide the reconstructed image from the annotatedimage or using the programming system to provide the reconstructed imagefrom the annotated image.

In Example 25, the subject matter of any one or any combination ofExamples 16-24 may optionally be configured such that a programmingsystem has a camera, and the picture is taken using the camera of theprogramming system.

In Example 26, the subject matter of any one or any combination ofExamples 16-25 may optionally be configured such that receiving userinput annotating the acquired image includes at least one of: receivinguser input annotating an orientation of the anatomy represented in theacquired image, or receiving user input annotating at least one labelfor a feature in the anatomy represented in the acquired image.

An example (e.g. Example 27) of subject matter (e.g. non-transitorycomputer-readable storage medium including instructions which whenexecuted using at least one processor within a system cause the systemto perform acts, a means for performing acts, or a method) may acquire adisplayed medical image from a medical imaging system, wherein thedisplayed medical image includes a representation of anatomy and arepresentation of at least one lead, wherein the at least one leadincludes electrodes, receive user input annotating the acquired image toprovide an annotated image, based on the acquired medical imagedetermine location data indicative of the position of at least one ofthe electrodes relative to at least one of the anatomy or at leastanother one of the electrodes, and provide the location data for use byat least one programming algorithm to program the neuromodulationdevice.

In Example 28, the subject matter of Example 27 may optionally beconfigured such that the programming system is configured to use thelocation data to determine energy contributions for the electrodes.

In Example 29, the subject matter of any one or any combination ofExamples 27-28 may optionally be configured such that acquire adisplayed medical image includes receive an image from a picture takenof the displayed image.

In Example 30, the subject matter of any one or any combination ofExamples 27-29 may optionally be configured such that the systemincludes a phone with a camera, and the picture taken of the displayedimage is taken by the phone.

In Example 31, the subject matter of any one or any combination ofExamples 27-30 may optionally be configured such that the acquired imageis a transitory image on the mobile device that is available forannotating the image and determining the location data but is notretrievably stored on the mobile device.

In Example 32, the subject matter of any one or any combination ofExamples 27-31 may optionally be configured to cause the phone toreceive user input annotating the acquired image to provide theannotated image.

In Example 33, the subject matter of any one or any combination ofExamples 27-32 may optionally be configured such that the instructions,which when executed using the at least one processor, cause the phone touse the annotated image to provide the reconstructed image.

In Example 34, the subject matter of any one or any combination ofExamples 27-33 may optionally be configured to cause the phone to usethe annotated image to determine location data indicative of thepositions of the electrodes and the anatomy.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments are illustrated by way of example in the figures ofthe accompanying drawings. Such embodiments are demonstrative and notintended to be exhaustive or exclusive embodiments of the presentsubject matter.

FIG. 1 illustrates, by way of example, an embodiment of aneuromodulation system.

FIG. 2 illustrates an embodiment of a modulation device, such as may beimplemented in the neuromodulation system of FIG. 1 .

FIG. 3 illustrates an embodiment of a programming system such as aprogramming device, which may be implemented as the programming devicein the neuromodulation system of FIG. 2 .

FIG. 4 illustrates, by way of example, an implantable neuromodulationsystem and portions of an environment in which system may be used.

FIG. 5 illustrates, by way of example, an embodiment of a SCS system.

FIG. 6 illustrates, by way of example, some features of theneuromodulation leads and a waveform generator.

FIG. 7 illustrates, by way of example, some differences between arepresentation of leads within conventional user interface for aprogramming system and a representation of leads within a fluoroscopicimage.

FIGS. 8A-8B illustrate, by way of example, an embodiment of a tool touse a medical image for neuromodulation programming.

FIG. 9 illustrates, by way of example, some functionality for anembodiment of an annotation tool, such as may be implemented within thetool illustrated in FIGS. 8A-8B.

FIG. 10 illustrates, by way of example, an embodiment of a userinterface configured for use to input information into the programmingsystem.

FIG. 11 illustrates, by way of example, an embodiment for determiningfractionalization to achieve an objective function.

FIG. 12 illustrates, by way of example, an embodiment for determiningfractionalization to achieve an objective function with more detail.

FIG. 13 illustrates a medical imaging system, a programming system forprogramming a neuromodulator such as a spinal cord stimulation (SCS)system, and bridging functions provided by the tool illustrated in FIGS.8A-8B to provide information to the programming system based on adisplayed image (e.g. fluoroscopic image) in the medical imaging system.

FIG. 14 illustrates an example of a system in which the image capturefunction is performed using the medical imaging system.

FIG. 15 illustrates an example of a system in which the programmingsystem is configured to perform the bridging functions.

FIG. 16 illustrates an example of a system that includes a mobile devicesuch as a phone programmed with an app or otherwise configured toperform the bridging functions between a displayed image (e.g.fluoroscopic image) in the medical imaging system and the programmingsystem.

FIG. 17 illustrates an example of a system that includes a mobile devicesuch as a phone or tablet programmed with an app or otherwise configuredto perform a portion of the bridging functions between a displayed image(e.g. fluoroscopic image) in the medical imaging system and theprogramming system, and the programming system is configured to performanother portion of the bridging functions.

FIG. 18 illustrates examples of data flow that may occur within varioussystem embodiments.

FIGS. 19A-B illustrate, by way of example, mapping a target electricalfield to an electrode array.

FIG. 20 illustrates an m×n transfer matrix used to determine therelative strengths of constituent current sources.

FIG. 21 illustrates an embodiment of a target multipole that includesfractionalized target anodes and fractionalized target cathodes designedto maximize the electric field in a region while minimizing the“activating function” (i.e. activation of dorsal columns, axons ofpassage) represented by the second difference of the extracellularpotentials generated by a field.

FIGS. 22A-22F generally illustrate the same target multipole with firstand second target anodes and first and second target cathodes.

DETAILED DESCRIPTION

The following detailed description of the present subject matter refersto the accompanying drawings which show, by way of illustration,specific aspects and embodiments in which the present subject matter maybe practiced. These embodiments are described in sufficient detail toenable those skilled in the art to practice the present subject matter.Other embodiments may be utilized and structural, logical, andelectrical changes may be made without departing from the scope of thepresent subject matter. References to “an”, “one”, or “various”embodiments in this disclosure are not necessarily to the sameembodiment, and such references contemplate more than one embodiment.The following detailed description is, therefore, not to be taken in alimiting sense, and the scope is defined only by the appended claims,along with the full scope of legal equivalents to which such claims areentitled.

Various embodiments described herein involve spinal cord modulation. Thecomplex spinal cord structure resides in a complex three-dimensionalenvironment. For example, the thickness of the cerebrospinal fluid(CSF), which is between the spinal cord and the epidural space, variesalong the spine. Thus, the distance between the spinal cord and one ormore neuromodulation leads within the epidural space likely varies.Furthermore, neither the leads nor the spinal cord form simple straightlines. The positions of implanted neuromodulation leads can also varyand are not perfectly parallel to the spinal cord. Additionally, theneuroanatomy of the spinal cord region can vary from patient-to-patient.It is desirable to accurately account for electrode positions to improvetherapy programming.

A brief description of the physiology of the spinal cord is providedherein to assist the reader. A spinal cord includes white matter andgray matter. The gray matter includes cell bodies, synapse, dendrites,and axon terminals. White matter includes myelinated axons that connectgray matter areas. A typical transverse section of the spinal cordincludes a central “butterfly” shaped central area of gray mattersubstantially surrounded by an ellipse-shaped outer area of whitematter. The white matter of the dorsal column (DC) includes mostly largemyelinated axons that form afferent fibers that run in an axialdirection. The dorsal portions of the “butterfly” shaped central area ofgray matter are referred to as dorsal horns (DH). In contrast to the DCfibers that run in an axial direction, DH fibers can be oriented in manydirections, including perpendicular to the longitudinal axis of thespinal cord. Examples of spinal nerves include a dorsal root (DR),dorsal root ganglion and ventral root. The dorsal root mostly carriessensory signals into the spinal cord, and the ventral root functions asan efferent motor root. The dorsal and ventral roots join to form mixedspinal nerves.

SCS has been used to alleviate pain. A therapeutic goal for conventionalSCS programming has been to maximize stimulation (i.e., recruitment) ofthe DC fibers that run in the white matter along the longitudinal axisof the spinal cord and minimal stimulation of other fibers that runperpendicular to the longitudinal axis of the spinal cord (dorsal rootfibers, predominantly. The white matter of the DC includes mostly largemyelinated axons that form afferent fibers. While the full mechanisms ofpain relief are not well understood, it is believed that the perceptionof pain signals is inhibited via the gate control theory of pain, whichsuggests that enhanced activity of innocuous touch or pressure afferentsvia electrical stimulation creates interneuronal activity within the DHof the spinal cord that releases inhibitory neurotransmitters(Gamma-Aminobutyric Acid (GABA), glycine), which in turn, reduces thehypersensitivity of wide dynamic range (WDR) sensory neurons to noxiousafferent input of pain signals traveling from the dorsal root (DR)neural fibers that innervate the pain region of the patient, as well astreating general WDR ectopy. Consequently, the large sensory afferentsof the DC nerve fibers have been conventionally targeted for stimulationat an amplitude that provides pain relief. Current implantableneuromodulation systems typically include electrodes implanted adjacent,i.e., resting near, or upon the dura, to the dorsal column of the spinalcord of the patient and along a longitudinal axis of the spinal cord ofthe patient.

Activation of large sensory DC nerve fibers also typically creates theparesthesia sensation that often accompanies conventional SCS therapy.Although alternative or artifactual sensations, such as paresthesia, areusually tolerated relative to the sensation of pain, patients sometimesreport these sensations to be uncomfortable, and therefore, they can beconsidered an adverse side-effect to neuromodulation therapy in somecases. Some embodiments deliver sub-perception therapy that istherapeutically effective to treat pain, for example. However, thepatient does not sense the delivery of the modulation field (e.g.paresthesia) during a sub-perception therapy. Sub-perception therapy maymodulate the spinal cord using a relatively high frequency modulation(e.g. about 1000 Hz or above). The high frequency modulation may include1200 Hz or above, and may include 1500 Hz or above. Some embodimentsherein selectively modulate DH tissue over DC tissue. Some embodimentsselectively stimulate DR tissue and/or dorsal root ganglion over DCtissue to provide sub-perception therapy. Such selective modulation maybe delivered at frequencies less than 1,200 Hz. The selective modulationmay be delivered at frequencies less than 1,000 Hz in some embodiments.In some embodiments, the selective modulation may be delivered atfrequencies less than 500 Hz. In some embodiments, the selectivemodulation may be delivered at frequencies less than 350 Hz. In someembodiments, the selective modulation may be delivered at frequenciesless than 130 Hz. The selective modulation may be delivered at lowfrequencies (e.g. as low as 2 Hz). The selective modulation may bedelivered even without pulses (e.g. 0 Hz) to modulate some neuraltissue. By way of example and not limitation, it is further noted thatthe selective modulation may be delivered with a duty cycle, in whichstimulation (e.g. a train of pulses) is delivered during a StimulationON portion of the duty cycle, and is not delivered during a StimulationOFF portion of the duty cycle. The selected modulation may be deliveredwith fixed or variable pulse widths.

FIG. 1 illustrates, by way of example, an embodiment of aneuromodulation system. The illustrated system 100 includes electrodes101, a modulation device 102, and a programming system such as aprogramming device 103. The programming system may include multipledevices. The electrodes 101 are configured to be placed on or near oneor more neural targets in a patient. For example, the electrodes 101 maybe on one or more leads implanted within the subdural space of thespinal cord. The modulation device 102 is configured to be electricallyconnected to electrodes 101 and deliver modulation energy, such as inthe form of electrical pulses, to the one or more neural targets thoughelectrodes 101. The delivery of the modulation energy is controlledusing a plurality of modulation parameters. The modulation parametersmay specify the electrical waveform (e.g. pulses or pulse patterns orother waveform shapes) and a selection of electrodes through which theelectrical waveform is delivered. In various embodiments, at least someparameters of the plurality of modulation parameters are programmable bya user, such as a physician or other caregiver. The programming device103 provides the user with accessibility to the user-programmableparameters. In various embodiments, the programming device 103 isconfigured to be communicatively coupled to modulation device via awired or wireless link. In various embodiments, the programming device103 includes a graphical user interface (GUI) 104 that allows the userto set and/or adjust values of the user-programmable modulationparameters.

FIG. 2 illustrates an embodiment of a modulation device 202, such as maybe implemented in the neuromodulation system 100 of FIG. 1 . Theillustrated embodiment of the modulation device 202 includes amodulation output circuit 205 and a modulation control circuit 206.Those of ordinary skill in the art will understand that theneuromodulation system 100 may include additional components such assensing circuitry for patient monitoring and/or feedback control of thetherapy, telemetry circuitry and power. The modulation output circuit205 produces and delivers the modulation energy. Neuromodulation pulsesare provided herein as an example. However, the present subject matteris not limited to pulses, but may include other electrical waveforms(e.g. waveforms with different waveform shapes, and waveforms withvarious pulse patterns). The modulation control circuit 206 controls thedelivery of the neuromodulation pulses or other waveforms using theplurality of neuromodulation parameters. The lead system 207 includesone or more leads each configured to be electrically connected tomodulation device 202 and a plurality of electrodes 201-1 to 201-Ndistributed in an electrode arrangement using the one or more leads.Each lead may have an electrode array consisting of two or moreelectrodes, which also may be referred to as contacts. Multiple leadsmay provide multiple electrode arrays to provide the electrodearrangement. Each electrode is a single electrically conductive contactproviding for an electrical interface between modulation output circuit205 and tissue of the patient, where N≥2. The neuromodulation pulses areeach delivered from the modulation output circuit 205 through a set ofelectrodes selected from the electrodes 201-1 to 201-N. The number ofleads and the number of electrodes on each lead may depend on, forexample, the distribution of target(s) of the neuromodulation and theneed for controlling the distribution of electric field at each target.In one embodiment, by way of example and not limitation, the lead systemincludes two leads each having eight electrodes. Some embodiments mayuse a lead system that includes a paddle lead.

The neuromodulation system may be configured to modulate spinal targettissue or other neural tissue. The configuration of electrodes used todeliver electrical pulses to the targeted tissue constitutes anelectrode configuration, with the electrodes capable of beingselectively programmed to act as anodes (positive), cathodes (negative),or left off (zero). In other words, an electrode configurationrepresents the polarity being positive, negative, or zero. An electricalwaveform may be controlled or varied for delivery using electrodeconfiguration(s). The electrical waveforms may be analog or digitalsignals. In some embodiments, the electrical waveform includes pulses.The pulses may be delivered in a regular, repeating pattern, or may bedelivered using complex patterns of pulses that appear to be irregular.Other parameters that may be controlled or varied include the amplitude,pulse width, and rate (or frequency) of the electrical pulses. Eachelectrode configuration, along with the electrical pulse parameters, canbe referred to as a “modulation parameter set.” Each set of modulationparameters, including fractionalized current distribution to theelectrodes (as percentage cathodic current, percentage anodic current,or off), may be stored and combined into a modulation program that canthen be used to modulate multiple regions within the patient.

The number of electrodes available combined with the ability to generatea variety of complex electrical waveforms (e.g. pulses) presents a hugeselection of modulation parameter sets to the clinician or patient. Forexample, if the neuromodulation system to be programmed has sixteenelectrodes, millions of modulation parameter sets may be available forprogramming into the neuromodulation system. Furthermore, for example,SCS systems may have thirty-two electrodes which exponentially increasesthe number of modulation parameters sets available for programming. Tofacilitate such selection, the clinician generally programs themodulation parameter sets through a computerized programming system toallow the optimum modulation parameters to be determined based onpatient feedback or other means and to subsequently program the desiredmodulation parameter sets.

FIG. 3 illustrates an embodiment of a programming system such as aprogramming device 303, which may be implemented as the programmingdevice 103 in the neuromodulation system of FIG. 1 . The programmingdevice 303 includes a storage device 308, a programming control circuit309, and a GUI 304. The programming control circuit 309 generates theplurality of modulation parameters that controls the delivery of theneuromodulation pulses according to the pattern of the neuromodulationpulses. In various embodiments, the GUI 304 includes any type ofpresentation device, such as interactive or non-interactive screens, andany type of user input devices that allow the user to program themodulation parameters, such as touchscreen, keyboard, keypad, touchpad,trackball, joystick, and mouse. The storage device 308 may store, amongother things, modulation parameters to be programmed into the modulationdevice. The programming device 303 may transmit the plurality ofmodulation parameters to the modulation device. In some embodiments, theprogramming device 303 may transmit power to the modulation device. Theprogramming control circuit 309 may generate the plurality of modulationparameters. In various embodiments, the programming control circuit 309may check values of the plurality of modulation parameters againstsafety rules to limit these values within constraints of the safetyrules.

In various embodiments, circuits of neuromodulation, including variousembodiments discussed in this document, may be implemented using acombination of hardware, software and firmware. For example, the circuitof GUI, modulation control circuit, and programming control circuit,including their various embodiments discussed in this document, may beimplemented using an application-specific circuit constructed to performone or more particular functions or a general-purpose circuit programmedto perform such function(s). Such a general-purpose circuit includes,but is not limited to, a microprocessor or a portion thereof, amicrocontroller or portions thereof, and a programmable logic circuit ora portion thereof.

FIG. 4 illustrates, by way of example, an implantable neuromodulationsystem and portions of an environment in which system may be used. Thesystem is illustrated for implantation near the spinal cord. Theillustrated system 410 includes an implantable system 411, an externalsystem 412, and a telemetry link 413 providing for wirelesscommunication between implantable system 411 and external system 412.The system 410 is illustrated as being implanted in the patient's body.The implantable system 411 includes an implantable neuromodulationdevice (also referred to as an implantable pulse generator, or IPG) 402,a lead system 407, and electrodes 401. The lead system 407 includes oneor more leads each configured to be electrically connected to themodulation device 402 and a plurality of electrodes 401 distributed inthe one or more leads. In various embodiments, the external system 412includes one or more external (non-implantable) devices each allowing auser (e.g. a clinician or other caregiver and/or the patient) tocommunicate with the implantable system 411. In some embodiments, theexternal system 412 includes a programming device intended for aclinician or other caregiver to initialize and adjust settings for theimplantable system 411 and a remote control device intended for use bythe patient. For example, the remote control device may allow thepatient to turn a therapy on and off and/or adjust certainpatient-programmable parameters of the plurality of modulationparameters.

The neuromodulation lead(s) of the lead system 407 may be placedadjacent, i.e., resting near, or upon the dura, adjacent to the spinalcord area to be stimulated. For example, the neuromodulation lead(s) maybe implanted along a longitudinal axis of the spinal cord of thepatient. Due to the lack of space near the location where theneuromodulation lead(s) exit the spinal column, the implantablemodulation device 402 may be implanted in a surgically-made pocketeither in the abdomen or above the buttocks, or may be implanted inother locations of the patient's body. The lead extension(s) may be usedto facilitate the implantation of the implantable modulation device 402away from the exit point of the neuromodulation lead(s).

FIG. 5 illustrates, by way of example, an embodiment of a SCS system,which also may be referred to as a Spinal Cord Modulation (SCM) system.The SCS system 514 may generally include a plurality (illustrated astwo) of implantable neuromodulation leads 515, an electrical waveformgenerator 516 such as an Implantable Pulse Generator (IPG), an externalremote controller RC 517, a clinician's programmer (CP) 518, and anexternal trial modulator (ETM) 519. IPGs are used herein as an exampleof the electrical waveform generator. However, it is expressly notedthat the waveform generator may be configured to deliver repeatingpatterns of pulses, irregular patterns of pulses where pulses havediffering amplitudes, pulse widths, pulse intervals, and bursts withdiffering number of pulses. It is also expressly noted that the waveformgenerator may be configured to deliver electrical waveforms other thanpulses. The waveform generator 516 may be physically connected via oneor more percutaneous lead extensions 520 to the neuromodulation leads515, which carry a plurality of electrodes 521. As illustrated, theneuromodulation leads 515 may be percutaneous leads with the electrodesarranged in-line along the neuromodulation leads. Any suitable number ofneuromodulation leads can be provided, including only one. A surgicalpaddle lead can be used in place of one or more of the percutaneousleads. In some embodiments, the waveform generator 516 may include pulsegeneration circuitry that delivers electrical modulation energy in theform of a pulsed electrical waveform (i.e., a temporal series ofelectrical pulses) to the electrodes in accordance with a set ofmodulation parameters.

The ETM 519 may also be physically connected via the percutaneous leadextensions 522 and external cable 523 to the neuromodulation leads 515.The ETM 519 may have similar waveform generation circuitry as thewaveform generator 516 to deliver electrical modulation energy to theelectrodes accordance with a set of modulation parameters. The ETM 519is a non-implantable device that is used on a trial basis after theneuromodulation leads 515 have been implanted and prior to implantationof the waveform generator 516, to test the responsiveness of themodulation that is to be provided. Functions described herein withrespect to the waveform generator 516 can likewise be performed withrespect to the ETM 519.

The RC 517 may be used to telemetrically control the ETM 519 via abi-directional RF communications link 524. The RC 517 may be used totelemetrically control the waveform generator 516 via a bi-directionalRF communications link 525. Such control allows the waveform generator516 to be turned on or off and to be programmed with differentmodulation parameter sets. The waveform generator 516 may also beoperated to modify the programmed modulation parameters to activelycontrol the characteristics of the electrical modulation energy outputby the waveform generator 516. A clinician may use the CP 518 to programmodulation parameters into the waveform generator 516 and ETM 519 in theoperating room and in follow-up sessions.

The CP 518 may indirectly communicate with the waveform generator 516 orETM 519, through the RC 517, via an IR communications link 526 or otherlink. The CP 518 may directly communicate with the waveform generator516 or ETM 519 via an RF communications link or other link (not shown).The modulation parameters provided by the CP 518 may also be used toprogram the RC 517, so that the modulation parameters can besubsequently modified by operation of the RC 517 in a stand-alone mode(i.e., without the assistance of the CP 518). Various devices mayfunction as the CP 518. Such devices may include portable devices suchas a lap-top personal computer, mini-computer, personal digitalassistant (PDA), tablets, phones, or a remote control (RC) with expandedfunctionality. Thus, the programming methodologies can be performed byexecuting software instructions contained within the CP 518.Alternatively, such programming methodologies can be performed usingfirmware or hardware. In any event, the CP 518 may actively control thecharacteristics of the electrical modulation generated by the waveformgenerator 516 to allow the desired parameters to be determined based onpatient feedback or other feedback and for subsequently programming thewaveform generator 516 with the desired modulation parameters. To allowthe user to perform these functions, the CP 518 may include a user inputdevice (e.g., a mouse and a keyboard), and a programming display screenhoused in a case. In addition to, or in lieu of, the mouse, otherdirectional programming devices may be used, such as a trackball,touchpad, joystick, touch screens or directional keys included as partof the keys associated with the keyboard. An external device (e.g. CP)may be programmed to provide display screen(s) that allow the clinicianto, among other functions, to select or enter patient profileinformation (e.g., name, birth date, patient identification, physician,diagnosis, and address), enter procedure information (e.g.,programming/follow-up, implant trial system, implant waveform generator,implant waveform generator and lead(s), replace waveform generator,replace waveform generator and leads, replace or revise leads, explant,etc.), generate a pain map of the patient, define the configuration andorientation of the leads, initiate and control the electrical modulationenergy output by the neuromodulation leads, and select and program theIPG with modulation parameters in both a surgical setting and a clinicalsetting.

An external charger 527 may be a portable device used totranscutaneously charge the waveform generator via a wireless link suchas an inductive link 528. Once the waveform generator has beenprogrammed, and its power source has been charged by the externalcharger or otherwise replenished, the waveform generator may function asprogrammed without the RC or CP being present.

FIG. 6 illustrates, by way of example, some features of theneuromodulation leads 615 and a waveform generator 616. The waveformgenerator 616 may be an implantable device or may be an external devicesuch as may be used to test the electrodes during an implantationprocedure. In the illustrated example, one of the neuromodulation leadshas eight electrodes (labeled E1-E8), and the other neuromodulation leadhas eight electrodes (labeled E9-E16). The actual number and shape ofleads and electrodes may vary for the intended application. Animplantable waveform generator may include an outer case for housing theelectronic and other components. The outer case may be composed of anelectrically conductive, biocompatible material, such as titanium, thatforms a hermetically-sealed compartment wherein the internal electronicsare protected from the body tissue and fluids. In some cases, the outercase may serve as an electrode (e.g. case electrode). The waveformgenerator may include electronic components, such as acontroller/processor (e.g., a microcontroller), memory, a battery,telemetry circuitry, monitoring circuitry, modulation output circuitry,and other suitable components known to those skilled in the art. Themicrocontroller executes a suitable program stored in memory, fordirecting and controlling the neuromodulation performed by the waveformgenerator. Electrical modulation energy is provided to the electrodes inaccordance with a set of modulation parameters programmed into the pulsegenerator. By way of example but not limitation, the electricalmodulation energy may be in the form of a pulsed electrical waveform.Such modulation parameters may comprise electrode combinations, whichdefine the electrodes that are activated as anodes (positive), cathodes(negative), and turned off (zero), percentage of modulation energyassigned to each electrode (fractionalized electrode configurations),and electrical pulse parameters, which define the pulse amplitude(measured in milliamps or volts depending on whether the pulse generatorsupplies constant current or constant voltage to the electrode array),pulse width (measured in microseconds), pulse rate (measured in pulsesper second), and burst rate (measured as the modulation on duration Xand modulation off duration Y). Electrodes that are selected to transmitor receive electrical energy are referred to herein as “activated,”while electrodes that are not selected to transmit or receive electricalenergy are referred to herein as “non-activated.”

Electrical modulation occurs between or among a plurality of activatedelectrodes, one of which may be the case of the waveform generator. Thesystem may be capable of transmitting modulation energy to the tissue ina monopolar or multipolar (e.g., bipolar, tripolar, etc.) fashion.Monopolar modulation occurs when a selected one of the lead electrodesis activated along with the case of the waveform generator, so thatmodulation energy is transmitted between the selected electrode andcase. Any of the electrodes E1-E16 and the case electrode may beassigned to up to k possible groups or timing “channels.” In oneembodiment, k may equal four. The timing channel identifies whichelectrodes are selected to synchronously source or sink current tocreate an electric field in the tissue to be stimulated. Amplitudes andpolarities of electrodes on a channel may vary. In particular, theelectrodes can be selected to be positive (anode, sourcing current),negative (cathode, sinking current), or off (no current) polarity in anyof the k timing channels. The waveform generator may be operated in amode to deliver electrical modulation energy that is therapeuticallyeffective and causes the patient to perceive delivery of the energy(e.g. therapeutically effective to relieve pain with perceivedparesthesia), and may be operated in a sub-perception mode to deliverelectrical modulation energy that is therapeutically effective and doesnot cause the patient to perceive delivery of the energy (e.g.therapeutically effective to relieve pain without perceivedparesthesia).

The waveform generator may be configured to individually control themagnitude of electrical current flowing through each of the electrodes.For example, a current generator may be configured to selectivelygenerate individual current-regulated amplitudes from independentcurrent sources for each electrode. In some embodiments, the pulsegenerator may have voltage regulated outputs. While individuallyprogrammable electrode amplitudes are desirable to achieve fine control,a single output source switched across electrodes may also be used,although with less fine control in programming. Neuromodulators may bedesigned with mixed current and voltage regulated devices. Calibrationtechniques are used to determine the proper current fractionalization.With the current fractionalized to a plurality of electrodes on theelectrical modulation lead, the resulting field can be calculated bysuperimposing the fields generated by the current delivered to eachelectrode.

Embodiments of the present subject matter relate to systems, devices,and methods used in programming neuromodulation. FIG. 7 illustrates, byway of example, some differences between a representation of leadswithin conventional user interface for a programming system and arepresentation of leads within a fluoroscopic image. Current userinterfaces, such as generally illustrated at 729, which are used toinput information into programming systems assume leads are parallel.Thus, a simplified representation of parallel lead(s) may be included onan anatomical template (e.g. spinal levels T8-T10). However, in the realworld, the leads are rarely parallel but rather may look similar to thefluoroscopic image illustrated at 730. Therefore, conventional userinterfaces do not provide the real lead location information found inmedical images such as fluoroscopic images, computed tomography (CT)images or magnetic resonance imaging (MRI) images. Thus, coordinatesprovided by conventional user interfaces to the programming systems donot accurately portray the real lead location. Additionally, theanatomical template in conventional user interfaces ignorepatient-specific anatomical variations (e.g. differences in spinallevels) and anatomical locations (e.g. dorsal horn (DH) and dorsalcolumn (DC) locations). Thus, it is not possible to develop reliableprogramming systems, even if improvements in lead detection aredeveloped, because the way in which images are collected has notstandardized in the field. For example, medical images such asfluoroscopic images commonly miss key information such as the lateralityof the spine (what is right, what is left), and the vertebral levelsthat are contained in the image (e.g. identification of T9-10). Theimages may be flipped such that a later viewer will not know which sidesrepresent the left and right sides of the patient. Also, if the image iszoomed in, then it may no longer include representations of anatomicallandmarks such that the viewer may not be able to determine thevertebral level within the image. Also, as the images of the spine canvary, some embodiments provide a stretchable label (e.g. stretchableruler) or individual markers to annotate the vertebral levels. Themarkers may be deformable to accommodate individual anatomicalvariations, vertebral levels, laterality, lead type, and the like. Theuser may be presented with predefined labeling that the user can droponto the image to annotate it. Often, the user is able to annotate 2-3vertebral levels within the image. However, the present subject matteris not limited to a particular number of vertebral levels. The systemmay be configured to enable a user to annotate lead(s) or electrodecontact(s) or location information for the electrode contact(s).

Various embodiments of the present subject matter are able to presentprecise electrode contact position information to programming systemswhich may include anatomically-guided field algorithms. By way ofexample, a picture may be taken to capture at least a portion of afluoroscopic image, the captured image may be annotated. Imageprocessing may be performed to detect leads within the image (eitherbefore or after annotation) and determine coordinates, which may then betransferred to the ETM or IPG (see 519 and 516 in FIG. 5 ) such as viaBluetooth or other wireless or wired communication means. A realisticfluoroscopic representation may be projected onto a template in the CP(see 518 in FIG. 5 ). SCS programming is improved because of therealistic anatomical information provided to the CP. In someembodiments, the contact positions (e.g. precisely-determinedcoordinates from the fluoroscopic image) may be fed into theanatomically-guided field algorithms.

FIGS. 8A-8B illustrate, by way of example, an embodiment of a tool touse a medical image for neuromodulation programming. At 831 a displayedmedical image is captured. For example, the medical image may bedisplayed during a procedure within an operating room. The capturedimage may be a portion of a medical image such as a fluoroscopic image.The image may be captured by a camera when the medical image isdisplayed on the medical imaging system. A camera in a mobile device,such as a phone or tablet, may be used to capture the image. Theprogrammer may have a camera that may be used to capture the image whendisplayed on the medical imaging system. In some embodiments, theimaging system may have graphical controls to clip or snip a portion ofthe image. At 832 the image may be annotated. For example, when theimage is captured by a mobile device such as a phone, the user interface(e.g. touch screen) of the mobile device may be used to annotate theimage. The system is configured to display the annotated image withadjustable markers, and the adjustable markers are configured to beadjusted by the user to accommodate individual spinal anatomy. Theannotated image includes at least one marker to identify at least one ofvertebral levels (e.g. T8, T9, T10) or laterality (left or L and rightor R) within the annotated image. At 833 image processing is performed.The image processing may detect the lead(s) and anatomical landmarkswithin the captured image as illustrated at 844 and may determinecoordinates of the lead(s) and anatomical landmark(s) for use inidentifying actual positions of the lead(s) and anatomical landmark(s)or the relative position of the lead(s) with respect to both each otherand the anatomical landmark(s) as illustrated at 835. The imageprocessing may be performed on the captured image or on the annotatedimage. At 836 lead(s) may be reconstructed on an image template, whichmay be used in user interface(s) that are configured for use to inputinformation into the programming system. Such user interfaces may allowthe user to also select a type of lead or the port of theneuromodulation device to which the lead is connected. The userinterface is able to provide data regarding location(s) and a desiredfield(s) to the programming system (e.g. 837A in FIG. 8A or 837B in FIG.8B). The programming system 837A or 837B may implement a program that isconfigured to use at least some of the data in programming theneuromodulation device. For example, the program may assist theclinician in selecting the appropriate stimulation configuration toachieve the desired field. Some embodiments of the programming system837B may implement an algorithm, as generally illustrated in FIG. 8B,which is configured to receive inputs such as the precise electrodecontact positions and the desired stimulation field, and determine theactive electrode and the energy contributions provided by the activeelectrodes as well as the intensity of the stimulation. The intensity ofthe stimulation is illustrated as amplitude but other stimulationparameters such as pulse width, frequency, burst frequency, burstduration, and the like may be used to adjust the intensity. Theprogramming system may use this information output by the algorithm todetermine the appropriate neuromodulation parameter set to program intothe neuromodulation device. It is noted that the illustrated functionsmay be implemented in other orders. For example, a portion or all of theimage processing may be performed before or during the annotationfunction.

FIG. 9 illustrates, by way of example, some functionality for anembodiment of an annotation tool, such as may be implemented within thetool illustrated in FIGS. 8A-8B. For example the annotation tool may beimplemented on a mobile device such as by an app on a phone or tablet,which may have been used to capture the image. However, the annotationtool may be implemented on other devices that have access to the image.As illustrated, the system is configured to display the annotated imagewith adjustable markers where the adjustable markers are configured tobe adjusted by the user to accommodate individual spinal anatomy. Theannotated image includes at least one marker to identify at least one ofvertebral levels or laterality within the annotated image. Moreparticularly, the illustrated embodiment includes a stretchable rulerwith vertebrae markers. The illustrated embodiment also includeinterchangeable right and left markers. The app may also be capable ofidentifying a lead port to the neuromodulation device, a lead type,image processing algorithms that may be used to automatically detectleads and extract coordinates of contacts, and communicate with otherdevices within a programming system. For example, location data may betransferred via a communication protocol (e.g. Bluetooth) to an ETM oran IPG which were previously illustrated in FIG. 5 .

FIG. 10 illustrates, by way of example, an embodiment of a userinterface configured for use to input information into the programmingsystem, such as was illustrated at 836 in FIG. 8A. The illustrated userinterface includes a template of the spine with labeled vertebral levelswith representations of the lead(s) accurately positioned over thetemplate. Such user interfaces may allow the user to also select a typeof lead (illustrated as “1×8”, “1×16”, “2×8”) or the port of theneuromodulation device to which the lead is connected, illustrated as“connections”, and other information that may be useful for theprogramming of the neuromodulation device with a stimulationconfiguration.

FIG. 11 illustrates, by way of example, an embodiment for determiningfractionalization (e.g. percent and polarity of active electrodes asillustrated in FIG. 8B) to achieve an objective function. An objectivefunction refers to a function with desirable characteristics formodulating the targeted tissue. The objective function may also bereferred to as an objective target function. An objective function 1138for a broad and uniform modulation field is identified for a givenvolume of tissue. Examples of an objective function includes a constantE (electric field), a constant |E| (electric field magnitude), and aconstant voltage. The lead and electrode configuration 1139, includingrelative positions to a physiological midline, are also identified, aswell as electrode tissue coupling 1140. A function 1141 is performedthat is dependent on the objective function, the electrode positions,and the electrode tissue coupling. The result of the function is thefractionalization of modulation energy (e.g. current) 1142 for eachelectrode to achieve the objective function. The fractionalization ofmodulation energy may be expressed, for each electrode, as a polarity(e.g. cathodic or anodic) and percentage of the total cathodic energy ortotal anodic energy delivered to the plurality of electrodes on the leadat a given time. Furthermore, an amplitude boost or scaling factor maybe applied to the fractionalization values.

FIG. 12 illustrates, by way of example, an embodiment for determiningfractionalization to achieve an objective function with more detail. Anobjective target function 1243 (e.g. constant E) is provided as an inputto a process. Other inputs to the process include a configuration option1244, a lead configuration 1245 and electrode contact status 1246, and athreshold 1247 such as a current threshold like a monopolar currentthreshold. The lead configuration 1245 and contact status 1246 identifyan electrode arrangement, identifying a position of each electrode todetermine the field. The overall field is a superimposed field from eachelectrode. The configuration option 1244 refers to monopolar (samepolarity for all activated electrodes) and multipolar options (combinedanode and cathodes in field). The threshold is used to compensate forelectrode/tissue coupling differences.

The contacts for stimulation may be determined automatically or manually1248 from the lead configuration and contact status. A selected fieldmodel may be used to estimate the field induced by unit current from thecontact 1249. The field may be calibrated using the threshold 1250. Forexample, the unit current field may be weighted. Constituent forces maybe formed based on the selected contacts 1251, and a transfer matrix1252 may be constructed for use to compute the minimal mean squaresolution 1254 using contributions from the constituent sources and usinga specified target field 1253. The solution may be used to compute thecurrent fractionalization on each contact 1255.

FIG. 13 illustrates a medical imaging system 1356, a programming system1357 for programming a neuromodulator such as a spinal cord stimulation(SCS) system, and bridging functions 1358 such as may be provided by thetool illustrated in FIGS. 8A-8B to provide information to theprogramming system based on a displayed image (e.g. fluoroscopic image)in the medical imaging system. The bridging functions 1358 provide aninformational bridge between the medical imaging system 1356 and theprogramming system 1357. The programming system 1357 may include asingle device such as a CP, or may include two or more devices such as,by way of example and not limitation, two or more of an RC, CP, andcloud-based system which may work together to program theneuromodulator. The programming system 1357 may include a calibrationfeature 1359 that is configured to use the location information (e.g.coordinates) to determine the relative or actual positions of theelectrode contacts and physiological features. The programming system1357 may include a user interface 1360, such as the interfaceillustrated in FIG. 10 for example, that may be configured for use toselect leads and modulation fields. The programing system 1357 mayinclude anatomically-guided field algorithms 1361 for use to generatethe stimulation configurations, including the energy contributions forindividual electrode contacts to provide the shape and size of themodulation field.

The bridging functions 1358 determine information contained within themedical image and provide data based on the medical image informationfor use by the programming system 1357 to improve programmingcapabilities. The bridging functions 1358 may include an image capturefunction 1362, an annotation function 1363, an image processing function1364 and an image reconstruction function 1364. These bridging functions1358 may be performed using one device or may be distributed across twoor more devices. The bridging functions 1358 may be implemented usingdevice(s) that are separate from the medical imaging system 1356 and theprogramming system 1357 or some of the bridging functions 1358 may beimplemented using at least one of the medical imaging system 1356 or theprogramming system.

FIG. 14 illustrates an example of a system in which the image capturefunction 1462 is performed using the medical imaging system 1456. Forexample, the medical imaging system 1456 may have graphical editingtools, such as snipping/clipping/copy tools, allowing the user to selecta portion of the displayed image such as may be done by dragging acursor to create a selection window on the displayed image. The selectedportion is a captured image. The image may then be shared with and usedby other bridging functions 1458 to determine information containedwithin the medical image and provide data based on the medical imageinformation to improve programming capabilities of the programmingsystem 1457.

FIG. 15 illustrates an example of a system in which the programmingsystem 1557 is configured to perform the bridging functions and theprogramming system 1557 based on a displayed image (e.g. fluoroscopicimage) in the medical imaging system 1556. The bridging functions may beperformed by one device or distributed over two or more devices withinthe programming system 1557. For example, a CP may include a devicecamera 1562 and an app or other program for providing image annotation1563, image processing 1564 and image reconstruction 1565. Thus, a CPmay use a camera to capture an image from the image display, and beconfigured to enable a user to annotate the image and perform imageprocessing to determine coordinates, and be configured to perform imagereconstruction to provide an accurate representation of electrodecontact location with respect to anatomical features beneficial forprogramming a neuromodulation device.

FIG. 16 illustrates an example of a system that includes a mobile device1666 such as a phone programmed with an app or otherwise configured toperform the bridging functions between a displayed image (e.g.fluoroscopic image) in the medical imaging system 1656 and theprogramming system 1657. Thus, a phone may be may use a camera tocapture an image from the image display, and be configured to enable auser to annotate the image and perform image processing to determinecoordinates, and be configured to perform image reconstruction toprovide an accurate representation of electrode contact location withrespect to anatomical features beneficial for programming aneuromodulation device. The mobile device is not limited to phones, asit may include tablets, laptops, and other devices.

FIG. 17 illustrates an example of a system that includes a mobile device1766 such as a phone or tablet programmed with an app or otherwiseconfigured to perform a portion of the bridging functions between adisplayed image (e.g. fluoroscopic image) in the medical imaging system1756 and the programming system 1757, and the programming system 1757 isconfigured to perform another portion of the bridging functions. Thus,by way of example and not limitation, an app operating a phone may usethe phone's camera to capture an image from the displayed image from themedical imaging system, and may be configured to enable a user toannotate the captured image using the phone touch screen interface. Theprogramming system 1757 may be configured to perform image processing todetermine coordinates, and be configured to perform image reconstructionto provide an accurate representation of electrode contact location withrespect to anatomical features beneficial for programming aneuromodulation device.

The type of data that moves between the various components depend on thebridging functions that being performed by the components. The data mayinclude data indicative of the captured image. The data may include dataindicative of the annotated image. The data may include data indicativeof the location of electrode contacts, location of lead(s), and locationof anatomical feature(s). The location data may include coordinates toestablish absolute or relative positions of the electrode contact(s) tothe anatomical feature(s). Examples of anatomical features may includeDC or DH fibers or a nerve root or ganglia at one or more targetedvertebral levels.

Some embodiments specifically exclude Personally IdentifiableInformation (PII) and Protected Health Information (PHI) from beingretrievably stored or transferred to the programming system. Examples ofPII include but are not limited to name, social security numbers,driver's license or other identification numbers, citizenship, gender,race, birth date and telephone numbers. For example, fluoroscopic imagesmay include meta data which may identify the patient's name, hospital,and the like. Examples of PHI include but are not limited to lab testresults, health histories, diagnosis, and the like. Various embodimentsintentionally exclude PII/PHI information from the captured image takenfrom the fluoroscopic image. Various embodiments intentionally preventPII/PHI information from being retrievably stored in the mobile deviceor other device within the system. The prevention of PII/PHI data frombeing retrievably stored may allow a temporary possession of the data ina transitory or ephemeral way. However, users are unable to access thatdata within the course of normal operations. For example, the mobiledevice app does not save an image beyond the current session, but willonly save coordinates and an identifier that does not qualify as a PIIor PHI data.

FIG. 18 illustrates examples of data flow that may occur within varioussystem embodiments. For example, as illustrated at 1867, the mobiledevice 1866 may be configured to directly communicate with theprogramming system 1857 to provide the data (e.g. data indicative oflocation such as coordinates or image-related data from which locationcan be determined) for use by the program implemented by the programmingsystem. Additionally or alternatively, as illustrated at 1868 and 1869,the data may be indirectly provided to the programming system 1857through a neuromodulator such as the implantable pulse generator (IPG)1870, or through a patient remote control or other device 1871, orthrough cloud-based service(s) and/or storage 1872. By way of example,embodiments that store the data in the neuromodulator (IPG or ETS) mayassist with the deidentification of the data because it would like thedata to the device and not the patient directly. The system may bedesigned to provide the data to the programming system using any one orany two or more of the illustrated ways. Thus, for example, the mobiledevice may be configured to provide the location data directly to theprogramming system and may also be configured to provide the locationdata to the neuromodulation device and the programming system isconfigured to receive the location data from the neuromodulation device.In some embodiments, the mobile device may provide the data (e.g. dataindicative of location such as coordinates or image-related data fromwhich location can be determined) to a cloud-based service(s)/storage,and the programming system can receive the data indicative of locationsuch as coordinates or image-related data from which location can bedetermined from the cloud-based service(s)/storage. Some embodiments mayuse a cloud-based platform at a cloud location to provide the imageprocessing and/or annotation and/or image reconstruction functions. Thedata indicative of location provided to the programming system (e.g. CP)may include data indicative of electrode-to-electrode distances andelectrode-to anatomical feature distances.

The programming system (e.g. CP) may implement a program that isconfigured to use the location data indicative of positions ofelectrodes and the anatomy to program the neuromodulation device. Withreference to FIGS. 19A-19B, the CP may implement programming algorithmsto map a target electrical field to the electrode array by estimatingthe field potential values (or some other linear electrical parameter,such as an activating function, current density, etc.) of the targetfield at a plurality of spatial observation points. The CP mayaccomplish this by determining the desired locations of target currentsource poles relative to the electrode array, and modeling an electricalfield generated by the target current source poles to determine desiredfield potential values at the spatial observation points (e.g., usinganalytical and/or numerical models).

Although target current source poles are one way to represent a “targetelectrical field”, other representations of target fields may be used.The locations of the target current source poles may be determined in amanner that places the resulting electrical field over an identifiedregion of the patient to be stimulated. The spatial observation pointsmay be spaced in a manner that would, at the least, cover the entiretissue region to be stimulated and/or would not cover a tissue regionthat should not be stimulated. The locations of the target currentsource poles may be defined by the user, and may be displayed to theuser along with the electrode locations, which as briefly discussedabove, may be determined based on electrical measurements taken at theelectrodes. The CP may select, or allow a user to select, a plurality ofconstituent current sources at the locations of the electrodes. Thelocations of the electrodes may be determined, at least in part, basedon the displayed image within the medical imaging system. Additionallyor alternatively, some embodiments may determine electrode locationsbased on measurements taken at the electrodes in response tosub-threshold electrical signals transmitted between the electrodes.

Once the constituent sources are selected, the CP may determine therelative strengths of the constituent current sources that, whencombined, result in estimated electrical field potential values at thespatial observation points that best matches the desired field potentialvalues at the spatial observation points. In particular, the CP maymodel the constituent current sources (e.g., using analytical and/ornumerical models) and estimate the field potential values per unitcurrent (V/mA) generated by each of the constituent current sources atthe spatial observation points, and may generate an m×n transfer matrix(shown in FIG. 20 ) from the estimated field potential values per unitcurrent, with m equaling the number of spatial observation points and nequaling the number of constituent sources. The relative strengths ofthe constituent current sources may be determined using an optimizationfunction that includes the transfer matrix A and the desired fieldpotential values.

The optimization function may be a least-squares (over-determined)function expressed as: |φ−Aĵ|², where φ is an m-element vector of thedesired field potential values, A is the transfer matrix, and ĵ is ann-element vector of the strengths of the constituent current sources.The constituent current source strengths j may be solved such that theoptimization function |φ−Aĵ|² is minimized. The square difference isminimized if φ=Aĵ. One approach for solving this problem may be toinvert the transfer matrix A and pre-multiply, such that A⁻¹=φA⁻¹Aĵ,which yields the solution ĵ=A⁻¹φ. Once the strengths of the constituentcurrent sources are determined, the CP converts these strengths tocurrent distributions on the electrodes in the form of a polarity andpercentage.

Improving the precision of the location data for the electrodes andanatomical target(s) input into these algorithms enhance theeffectiveness of the programmed stimulation configuration. Suchimprovements may be useful for delivering sub-perception modulation ofthe DH or DR tissue over DC tissue. However, some embodiments may beused to deliver other modulation therapies.

Neural tissue in the region of the spinal cord has differentcharacteristics. For example, DC fibers (mostly myelinated axons) run inan axial direction, whereas DH (e.g. neuronal cell terminals, neuronalcell bodies, dendrites, and axons) fibers are oriented in manydirections. The distance from typically-placed epidural SCS leads to DHfibers are different than the distance from these leads to DC fibers.Further, DH fibers and dorsal column fibers have different responses(e.g. activation functions) to electrical modulation. The strength ofmodulation (i.e., depolarizing or hyperpolarizing) of the DC fibers andneurons is described by the so-called “activation function” which isproportional to the second-order spatial derivative of the voltage alongthe longitudinal axis of the spine (∂2V/∂x2). This is partially becausethe large myelinated axons in DC are primarily aligned longitudinallyalong the spine. On the other hand, the likelihood of generating actionpotentials in DH fibers and neurons is described by an activatingfunction that is proportion to the first-order spatial derivative of thevoltage along the spine (∂V/∂x), which is otherwise known as theelectric field. Thus, the DH activating function is proportional to thefirst-order derivative of the voltage along the fiber axis, whereas theDC activating function is proportional to the second-order derivative ofthe voltage along the fiber axis. Accordingly, the distance from theelectrical field locus affects the DH activating function (∂V/∂x) lessthan it affects the dorsal column activating function ∂2V/∂x2. Theneuronal elements (e.g., neurons, dendrites, axons, cell bodies, andneuronal cell terminals) in the DH can be preferentially stimulated overthe DC neuronal elements by minimizing the longitudinal gradient of anelectrical field generated by a neuromodulation lead along the DC,thereby providing therapy in the form of pain relief without creatingthe sensation of paresthesia. DH fibers and DC fibers have differentresponses (activation functions) to electrical modulation.

Various embodiments for enhancing modulation field selectively modulateDH and/or DR tissue over DC tissue. Conventional SCS activates DC fiberaxons, and the orthodromic propagation of action potentials inducesperception of paresthesia in the brain and antidromic propagation ofaction potentials to fiber collaterals and terminals ending in DH evokespain control mechanism in DH. Various embodiments shape the stimulationfield to preferably stimulate fiber terminals ending in DH and/or DR toprovide pain relief without inducing paresthesia. For example,uniformity in a first order gradient of voltage (i.e. uniformity inelectric field) may be more efficient in stimulating DH fiber terminalsand/or stimulating DR fibers. Uniformity across a larger field mayeliminate the needs for searching optimal stimulation site and createbroader coverage of pain. For example, the uniformity may extend betweenor among two or more electrodes within an arrangement of electrodes. Inother examples, the uniformity may extend among three, four, five, sixor more electrodes within an arrangement of electrodes to eliminate theneeds for searching for an optimal simulation site and creating abroader therapeutic coverage. Thus, the uniformity extends over asubstantial portion of the lead. Some embodiments are configured todetermine a modulation parameter set to create a field shape to providea broad and uniform modulation field to enhance modulation of targetedneural tissue (e.g. DH tissue or DR tissue). Some embodiments areconfigured to determine a modulation parameter set to create a fieldshape to reduce or minimize modulation of non-targeted tissue (e.g. DCtissue).

Various embodiments disclosed herein are directed to shaping themodulation field to enhance modulation of some neural structures anddiminish modulation at other neural structures. The modulation field maybe shaped by using multiple independent current control (MICC) ormultiple independent voltage control to guide the estimate of currentfractionalization among multiple electrodes and estimate a totalamplitude that provide a desired strength. For example, the modulationfield may be shaped to enhance the modulation of DH neural tissue and tominimize the modulation of DC tissue. A benefit of MICC is that MICCaccounts for various in electrode-tissue coupling efficiency andperception threshold at each individual contact. This capability of MICCalong with precise location data determined from the captured imageimproves the ability to precisely apply a modulation field with adesirable shape to precisely target neuroanatomy

For example the modulation field may be shaped to provide a constantelectric field (E) at the DH tissue in a selected direction. Theelectric field (E) at the DH in any direction is the negative gradient(negative rate of change) of the scalar potential field (V) in thatdirection. Due to the linearity of field superposition, a transferfunction can be formed to estimate the EDH(x,y,z) at selected directioninduced by unit current from a single electrode located at (x0, y0, z0),the total E field is the linear combination of the E field induced bycurrents from each active electrode weighted by the currentfractionalization. In an example, the modulation field may be a constantV field along the DC tissue. Due to the linearity of fieldsuperposition, a transfer function can be formed to estimate theVDC(x,y,z) at selected direction induced by unit current from a singleelectrode located at (x0, y0, z0), the total V field is the linearcombination of the V field induced by currents from each activeelectrode weighted by the current fractionalization.

Various embodiments may design a field to maximize the linearprogression of extracellular voltages in the rostral-caudal directionfor subthreshold and suprathreshold activation of terminals oriented inthe anterior posterior (AP) direction. Various embodiments of thepresent subject matter produce a linear field by stackingfractionalizations of target poles in a directional, progressive manner.

As a particular example, FIG. 21 illustrates an embodiment of a targetmultipole that includes fractionalized target anodes and fractionalizedtarget cathodes designed to maximize the electric field in a regionwhile minimizing the “activating function” (i.e. activation of dorsalcolumns, axons of passage) represented by the second difference of theextracellular potentials generated by a field. The target multipoleillustrated in FIG. 21 progressively stacks fractionalization of targetpoles. The illustrated target multipole may be referred to as a basefield design, as it may serve as a base from which the field length,width and orientation may be adjusted, and as a base from which featuressuch as flanking electrodes may be added. In the illustrated embodiment,the target multipole includes first and second target anodes where inthe first target anode 2173 represents 33% of the total anodic currentand the second target anode 2174 represents 67% of the total anodiccurrent; and further includes first and second target cathodes where inthe first target cathode 2175 represents 33% of the total cathodiccurrent and the second target anode 2176 represents 67% of the totalcathodic current. Other percentages may be used to progressivelyincrease the percentage moving away from the center of the targetmultipole and/or to alter the length of the target field. Someembodiments may include more than two target anodes in which thepercentage of anodic current progressively increases away from thecenter of the target multipole. Some embodiments may include more thantwo target cathodes in which the percentage of cathodic currentprogressively increases away from the center of the target multipole.Some embodiments may include one target anode (100%) and more than onetarget cathode. Some embodiments may include one target cathode (100%)and more than one target anode.

As a more particular example, FIGS. 22A-22F generally illustrate thesame target multipole with first and second target anodes and first andsecond target cathodes. The second target anode is larger than the firsttarget anode, and the second target cathode is larger than the firsttarget cathode. The fractionalized current delivered to the underlyingphysical electrodes may be adjusted to precisely move the targetmultipole, by way of example and not limitation, to be centeredlaterally on the left column of electrodes with the target polescentered longitudinally at 25% from the electrode top (FIG. 22A), to becentered laterally on the left column of electrodes with the targetpoles centered longitudinally between rows in the left column ofelectrodes (FIG. 22B), to be centered laterally on the left column ofelectrodes with the target poles centered longitudinally on electrodesin the left column of electrodes (FIG. 22C), to be centered laterally ona midline between the columns and centered longitudinally with electroderows (FIG. 22D), to be centered laterally on a midline between thecolumns with the target poles centered longitudinally at 25% from theelectrode row top (FIG. 22E), and to be centered laterally on a midlinebetween the columns with the target poles centered longitudinallybetween rows of electrodes (FIG. 22F).

Various embodiments disclosed herein may use a computer system, withinwhich a set or sequence of instructions may be executed to cause themachine to perform methodologies discussed herein. In alternativeembodiments, the machine operates as a standalone device or may beconnected (e.g., networked) to other machines. In a networkeddeployment, the machine may operate in the capacity of either a serveror a client machine in server-client network environments, or it may actas a peer machine in peer-to-peer (or distributed) network environments.The machine may be a personal computer (PC), a tablet PC, a hybridtablet, a personal digital assistant (PDA), a mobile telephone, animplantable pulse generator (IPG), an external remote control (RC), aUser's Programmer (CP), or any machine capable of executing instructions(sequential or otherwise) that specify actions to be taken by thatmachine. Further, the term “machine” shall also be taken to include anycollection of machines that individually or jointly execute a set (ormultiple sets) of instructions to perform any one or more of themethodologies discussed herein. One or more machines that are controlledby or operated by one or more processors (e.g., a computer) toindividually or jointly execute instructions to perform any one or moreof the methodologies discussed herein.

An example of a computer system includes at least one processor (e.g., acentral processing unit (CPU), a graphics processing unit (GPU) or both,processor cores, compute nodes, etc.), a main memory and a staticmemory, which communicate with each other via a link (e.g., bus). Thecomputer system may further include a video display unit, analphanumeric input device (e.g., a keyboard), and a user interface (UI)navigation device (e.g., a mouse). In one embodiment, the video displayunit, input device and UI navigation device are incorporated into atouch screen display. The computer system may additionally include astorage device (e.g., a drive unit), a signal generation device (e.g., aspeaker), a network interface device, and one or more sensors (notshown), such as a global positioning system (GPS) sensor, compass,accelerometer, or other sensor. It will be understood that other formsof machines or apparatuses (such as IPG, RC, CP devices, and the like)that are capable of implementing the methodologies discussed in thisdisclosure may not incorporate or utilize every one of these components(such as a GPU, video display unit, keyboard, etc.). The storage devicemay include a machine-readable medium on which is stored one or moresets of data structures and instructions (e.g., software) embodying orutilized by methodologies or functions described herein. Theinstructions may also reside, completely or at least partially, withinthe main memory, static memory, and/or within the processor duringexecution thereof by the computer system, with the main memory, staticmemory, and the processor also constituting machine-readable media.While the machine-readable medium is illustrated in an exampleembodiment to be a single medium, the term “machine-readable medium” mayinclude a single medium or multiple media (e.g., a centralized ordistributed database, and/or associated caches and servers) that storethe one or more instructions. The term “machine-readable medium” shallalso be taken to include any tangible (e.g., non-transitory) medium thatis capable of storing, encoding or carrying instructions for executionby the machine and that cause the machine to perform any one or more ofthe methodologies of the present disclosure or that is capable ofstoring, encoding or carrying data structures utilized by or associatedwith such instructions. The term “machine-readable medium” shallaccordingly be taken to include, but not be limited to, solid-statememories, and optical and magnetic media. Specific examples ofmachine-readable media include non-volatile memory, including but notlimited to, by way of example, semiconductor memory devices (e.g.,electrically programmable read-only memory (EPROM), electricallyerasable programmable read-only memory (EEPROM)) and flash memorydevices; magnetic disks such as internal hard disks and removable disks;magneto-optical disks; and CD-ROM and DVD-ROM disks. The instructionsmay further be transmitted or received over a communications networkusing a transmission medium via the network interface device utilizingany one of a number of well-known transfer protocols (e.g., HTTP).Examples of communication networks include a local area network (LAN), awide area network (WAN), the Internet, mobile telephone networks, plainold telephone (POTS) networks, and wireless data networks (e.g., Wi-Fi,3G, and 4G LTE/LTE-A or 5G networks). The term “transmission medium”shall be taken to include any intangible medium that is capable ofstoring, encoding, or carrying instructions for execution by themachine, and includes digital or analog communications signals or otherintangible medium to facilitate communication of such software.

The above detailed description is intended to be illustrative, and notrestrictive. The scope of the disclosure should, therefore, bedetermined with references to the appended claims, along with the fullscope of equivalents to which such claims are entitled.

What is claimed is:
 1. A method performed using a mobile device with amedical imaging system and a programming system, wherein the medicalimaging system is configured to display a medical image and theprogramming system is configured to implement a program used inprogramming a neuromodulation device, the method comprising: taking apicture of the displayed medical image from the medical imaging systemusing a camera from the mobile device, wherein the displayed medicalimage includes a representation of anatomy and a representation of atleast one electrode; annotating the picture to provide an annotatedimage; determining location data based on the annotated image indicativeof a position of at least one of the electrodes relative to at least oneof the anatomy or at least another one of the electrodes; and providingto the programming system location data for use by the programmingsystem to program the neuromodulation device.
 2. The method of claim 1,wherein the mobile device includes a phone.
 3. The method of claim 1,wherein the picture is a transitory image on the mobile device that isavailable for the annotating and the determining the location dataduring a current session but is not retrievably stored on the mobiledevice for access after the current session.
 4. The method of claim 1,wherein the annotating includes identifying at least one of vertebrallevels, laterality, lead type, at least one electrode contact, orlocation information for at least one electrode contact
 5. The method ofclaim 4, wherein the receiving user input annotating the acquired imageincludes using adjustable markers to accommodate individual spinalanatomy.
 6. The method of claim 1, wherein the annotating includes usinginterchangeable right and left markers to indicate laterality.
 7. Themethod of claim 1, wherein the annotating includes at least one of:annotating an orientation of the anatomy represented in the acquiredimage, or annotating at least one label for a feature in the anatomyrepresented in the acquired image.
 8. The method of claim 1, wherein theprogramming system is configured to use the location data to determineenergy contributions for the electrodes.
 9. The method of claim 1,wherein the medical imaging system includes a fluoroscopy imaging systemand the displayed image is a displayed fluoroscopic image, and thedisplayed image includes a representation of at least one lead implantedproximate to a spine.
 10. A non-transitory computer-readable storagemedium including instructions, which when executed using at least oneprocessor within a mobile device, cause the mobile device to perform amethod, comprising: responding to user actuation by taking a picture ofthe displayed medical image from the medical imaging system using acamera from the mobile device, wherein the displayed medical imageincludes a representation of anatomy and a representation of at leastone electrode; receiving user input annotating the picture to provide anannotated image; determining location data based on the annotated imageindicative of a position of at least one of the electrodes relative toat least one of the anatomy or at least another one of the electrodes;and providing to the programming system location data for use by theprogramming system to program the neuromodulation device.
 11. Thenon-transitory computer-readable storage medium of claim 10, wherein theinstructions, which when executed using the at least one processor,cause the mobile device to use the annotated image to determine locationdata indicative of the positions of the electrodes and the anatomy. 12.The non-transitory computer-readable storage medium of claim 10, whereinthe programming system is configured to use the location data todetermine energy contributions for the electrodes and program theneuromodulation device according to the determined energy contributions.13. The non-transitory computer-readable storage medium of claim 10,wherein the annotations include an orientation of the anatomyrepresented in the acquired image, or at least one label for a featurein the anatomy represented in the acquired image.
 14. The non-transitorycomputer-readable storage medium of claim 10, wherein the mobile deviceincludes a phone, and the picture taken of the displayed image is takenusing the phone.
 15. The non-transitory computer-readable storage mediumof claim 10, wherein the picture is a transitory image on the mobiledevice that is available for annotating the image and determining thelocation data during a current session but is not retrievably stored onthe mobile device for access after the current session.
 16. A system foruse with a medical imaging system and a programming system, wherein themedical imaging system is configured to display a medical image and theprogramming system is configured to implement a program used inprogramming a neuromodulation device, the system comprising a mobiledevice having at least one processor, a camera and a user interfaceincluding a display, wherein the mobile device is configured to: take apicture of the displayed medical image from the medical imaging systemusing a camera from the mobile device, wherein the displayed medicalimage includes a representation of anatomy and a representation of atleast one electrode; receive user input annotating the picture toprovide an annotated image: determine location data based on theannotated image indicative of a position of at least one of theelectrodes relative to at least one of the anatomy or at least anotherone of the electrodes; and provide to the programming system locationdata for use by the programming system to program the neuromodulationdevice.
 17. The system of claim 16, wherein the mobile device includes aphone.
 18. The system of claim 16, wherein the picture is a transitoryimage on the mobile device that is available to be annotated and for thelocation data to be determined during a current session but is notretrievably stored on the mobile device for access after the currentsession.
 19. The system of claim 16, wherein the programming system isconfigured to use the location data to determine energy contributionsfor the electrodes.
 20. The system of claim 16, wherein the medicalimaging system includes a fluoroscopy imaging system and the displayedimage is a displayed fluoroscopic image, and the displayed imageincludes a representation of at least one lead implanted proximate to aspine.